A variety of surgical treatments have recently become available to address abdominal and pelvic disease including obesity and related disorders. In the medical field many therapeutic upper gastrointestinal (UGI) tract procedures are routinely performed by flexible endoscopy, without creating an external surgical opening. In such procedures an endoscope is introduced via the patient's mouth, through the patient's oropharynx and esophagus into the lumen of the stomach.
The endoscopes used in the industry include a light delivery system for illuminating the interior of an organ and may be used to evaluate the site, an ability to insufflate air into the gastrointestinal lumen, and also have a narrow working channel to allow for easy introduction of instruments in the patient for performing procedures such as obtaining biopsy specimens, cauterization, and polyp removal. Minimally invasive procedures are desired by both the medical personnel and the patient, because of the potential for quicker recovery and reduced surgical complications. However, use of endoscope instruments limits the ease of use due to the small diameter of the working channel which limits the size and type of instruments that may be used as well as the procedures that can be performed.
In addition to the small diameter of the working channel, all instruments by the very nature of the flexible endoscopy platform are introduced in a “parallel” relation to each other as well as the endoscope itself which results in an inherently limiting factor for performing advanced endolumenal and extralumenal procedures. This limiting factor prevents the physician in using these instruments in an otherwise standard surgical means, process and technique called triangulation of the instruments. This inability to triangulate instruments limits the types of procedures that can be performed by the current standard flexible endoscopy platform. This includes not only the instruments and devices passed through the working channel or channels of the endoscope but in addition includes any instruments or devices that have previously been developed for attaching themselves to the side or tip of the endoscope. In addition, the efficiency of the available procedures is less than optimal.
Because passage of a flexible endoscope for UGI procedures by its very nature must past through the oropharynx; the size of the oropharynx becomes a limiting factor. Thus, only a single endoscope which can only vary minimally in diameter may be inserted at any one time via the patient's esophagus. These aspects effectively have precluded, or increased the risk of complications from the use of endoscopic introduced instruments to create access via an opening from the lumen of the stomach and/or into the extralumenal space, such as the peritoneal cavity, perform a surgical procedure, withdraw the instrument, and close the opening.
Limitations on general endoscopic procedures have also limited the performance and advancement of endolumenal endoscopic procedures. The use of standard flexible endoscopy has created minimal treatment options or surgical options for evaluation and treatment in the gastrointestinal tract. The current industry has tried unsuccessfully to develop and expand the role of standard flexible endoscopy and the creation of a platform of instruments which could be used to perform advanced intralumenal endoscopic procedures as well as extralumenal procedures. One example has been natural orifice translumenal endoscopic surgery (NOTES). NOTES was developed to expand the role of standard flexible endoscopy and provide a platform and instruments which could be used to perform advanced intralumenal endoscopic procedures as well as extralumenal procedures. The NOTES concept and platform has not been successfully integrated into standard GI endoscopy or surgical procedures due to the bulky instruments which are difficult to pass safely through the oropharynx. The current NOTES devices in the industry have not met the required elements for success in accessing the extralumenal space, performance of the procedure, and closure of the opening.
In addition to the use of an endoscope for minimal invasive surgical procedures, laparoscopic surgery is another option. In laparoscopic surgery multiple small surgical openings are created through the abdominal wall and tissue and a laparoscope is introduced through one of the openings and into the peritoneal cavity. The laparoscope is able by its very nature to examine the outside of the gastrointestinal tract and the solid organs of the abdominal-pelvic cavity and intraperitoneal space. Trocars, hollow tubes with sharp tips, are introduced into the other openings and instruments are introduced into the peritoneal cavity through the trocars to perform surgical operations on the outside of the abdominal organs such as the stomach, small intestine, colon, spleen, gall bladder, pancreas and liver. Access to these organs via laparoscopic surgery is extralumenal, from the peritoneal cavity, rather than endolumenal through the lumens of the gastrointestinal tract. In addition, such current endoscopic and laparoscopic surgical devices and procedures do not have the ability or a device designed and available to provide both external and internal anchors to retain the wall of the stomach in place against the abdominal wall during the procedure for both intraluminal and extralumenal access to provide a safe, stable, and reliable working channel which traverses and stabilizes the abdominal wall and gastric wall between the internal and external anchors. In addition, such current endoscopic and laparoscopic surgical procedures do not have the ability or a device to provide an endoscopically placed trocar or access device to provide the ability for the simultaneous access to the GI tract and peritoneal cavity for both intralumenal and extralumenal procedures.
It is also known in the industry to use percutaneous endoscopic gastrostomy (PEG) tubes for feeding and delivery of nutrients to a patient. A PEG is put in place by insertion through a surgical opening or stoma into the stomach of a patient to allow for fluid passage. The PEG feeding tubes must be soft and flexible and are generally formed of silicone or the like, which could be easily punctured by surgical instruments. The design is important for the desired purpose, but lacks the ability for insertion of surgical or medical devices or to perform surgical procedures. Further the similar limiting factors found in endoscopic procedures are also found with the PEG because of the size and weakness of material required for the PEG.
There is a need for a trans-abdominal gastric surgery system that provides new and unique device or system and introducer device to create a minimally invasive single port access with a working channel for the introduction of instruments used to access the gastric lumen, peritoneal space, or retroperitoneal space. The system further requires an anchoring system with internal and external anchors to stabilize the gastric and abdominal wall while creating a luminal access. A system is also desired that is easier to use by a medical professional by providing “triangulation” of both laparoscopic and endoscopic instruments and minimizes the pain and post-op recovery by a patient. A system that provides for a sealed access to simultaneously allow intraluminal surgical access to the stomach lumen and through the lumen of the upper GI tract or also out into the peritoneal cavity or retroperitoneal space, that permits the passage, use, and rotation of surgical instruments through a single cannula having multiple ports or multiple cannulas that permit “triangulation” necessary for accurate performance of delicate procedures. The system further desired includes the ability for air or CO2 insufflation to control and monitor the pressure during the procedure. Further, a system is desired that allows for adjustment of the length and radial diameter of the cannula, that further provides an adjustable internal fixation device through which multiple instruments may pass, and can remain in a patient's body for the duration of the procedure and once removed can provide an easy and efficient method of closure of the transabdominal access following the removal of medical instruments.
Further, there is a need for an introducer and device that allows for performing intralumenal and extralumenal procedures that can further include standard endoscopic and laparoscopic platforms, but overcomes the limitations currently found due to size constraints and lack of triangulation.